Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00453206
First received: March 27, 2007
Last updated: September 11, 2014
Last verified: September 2014
Results First Received: May 28, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions: Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant

Participant Flow:   Overall Study
    Reduced Intensity Allogeneic Cell Transplantation  
STARTED     66  
COMPLETED     65  
NOT COMPLETED     1  
Death                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant

Baseline Measures
    Reduced Intensity Allogeneic Cell Transplantation  
Number of Participants  
[units: participants]
  66  
Age  
[units: years]
Mean ± Standard Deviation
  60.1  ± 7.5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     48  
>=65 years     18  
Gender  
[units: participants]
 
Female     21  
Male     45  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     64  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     65  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     66  



  Outcome Measures

1.  Primary:   Treatment-related Mortality Within the First 6 Months After Transplantation   [ Time Frame: 6 months ]

2.  Secondary:   Complete Response   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Survival   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Disease-free Survival   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Graft-versus-host Disease   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Iron Status at the Time of Transplantation   [ Time Frame: baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Quality of Life at the Time of Transplantation   [ Time Frame: baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Treatment-related Mortality at 100 Days After Transplantation   [ Time Frame: 100 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
By the time the primary objective of this trial was completed, the treatment approach of the trial had become standard of care. Analysis was therefore limited.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Hurd, MD
Organization: Wake Forest University Health Sciences
phone: 336-716-2843
e-mail: dhurd@wakehealth.edu


No publications provided


Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00453206     History of Changes
Other Study ID Numbers: CDR0000538185, CCCWFU-29506, IRB00001366
Study First Received: March 27, 2007
Results First Received: May 28, 2014
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board